Improving the value of clinical research through the use of Common Data Elements

Jerry Sheehan; Steven Hirschfeld; Erin Foster; Udi Ghitza; Kerry Goetz; Joanna Karpinski; Lisa Lang; Richard P Moser; Joanne Odenkirchen; Dianne Reeves; Yaffa Rubinstein; Ellen Werner; Michael Huerta

doi:10.1177/1740774516653238

Improving the value of clinical research through the use of Common Data Elements

Clin Trials. 2016 Dec;13(6):671-676. doi: 10.1177/1740774516653238. Epub 2016 Jun 15.

Authors

Affiliations

¹ National Library of Medicine, National Institutes of Health, Bethesda, MD, USA.
² Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
³ National Institute on Drug Abuse, National Institutes of Health, Bethesda, MD, USA.
⁴ National Eye Institute, National Institutes of Health, Bethesda, MD, USA.
⁵ National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
⁶ National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.
⁷ National Center for Advancing Translational Sciences, National Institutes of Health, Bethesda, MD, USA.
⁸ National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, MD, USA.
⁹ National Library of Medicine, National Institutes of Health, Bethesda, MD, USA mike.huerta@nih.hhs.gov.

Abstract

The use of Common Data Elements can facilitate cross-study comparisons, data aggregation, and meta-analyses; simplify training and operations; improve overall efficiency; promote interoperability between different systems; and improve the quality of data collection. A Common Data Element is a combination of a precisely defined question (variable) paired with a specified set of responses to the question that is common to multiple datasets or used across different studies. Common Data Elements, especially when they conform to accepted standards, are identified by research communities from variable sets currently in use or are newly developed to address a designated data need. There are no formal international specifications governing the construction or use of Common Data Elements. Consequently, Common Data Elements tend to be made available by research communities on an empiric basis. Some limitations of Common Data Elements are that there may still be differences across studies in the interpretation and implementation of the Common Data Elements, variable validity in different populations, and inhibition by some existing research practices and the use of legacy data systems. Current National Institutes of Health efforts to support Common Data Element use are linked to the strengthening of National Institutes of Health Data Sharing policies and the investments in data repositories. Initiatives include cross-domain and domain-specific resources, construction of a Common Data Element Portal, and establishment of trans-National Institutes of Health working groups to address technical and implementation topics. The National Institutes of Health is seeking to lower the barriers to Common Data Element use through greater awareness and encourage the culture change necessary for their uptake and use. As National Institutes of Health, other agencies, professional societies, patient registries, and advocacy groups continue efforts to develop and promote the responsible use of Common Data Elements, particularly if linked to accepted data standards and terminologies, continued engagement with and feedback from the research community will remain important.

Keywords: Common Data Elements; data collection; data sharing; data standards; interoperability.

MeSH terms

Biomedical Research*
Common Data Elements*
Data Collection
Humans
Information Dissemination*
National Institutes of Health (U.S.)
United States

Grants and funding

Z99 HD999999/Intramural NIH HHS/United States